Elastomeric parts for parenterals and for devices for pharmaceutical use - Determination of released-particle count Ingestion-build-83346 medical gas pipeline sustems covered

medical gas pipeline sustems covered by ISO 7396-1 (68)

Additional information for heat meters

rail and inland navigation

Other EEE stakeholders

Heating and melting glass equipment

Elastomeric parts for parenterals and for devices for pharmaceutical use - Determination of released-particle count Ingestion-build-83346 medical gas pipeline sustems coveredWhat is this standard about? Elastomeric closures may be superficially contaminated with visible and subvisible particles, and fragments can also be produced when the closure is pierced by a needle. Such particles may be transferred to pharmaceutical preparations in contact with the elastomeric parts and affect the quality of such preparations. This part of ISO 8871 specifies methods for the determination of the number of visible and subvisible